Active vs. Passive VR During Office-based ENT Procedures

NCT07599826 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00004672
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to evaluate whether active virtual reality reduces pain and anxiety more effectively than passive virtual reality during office-based ENT procedures. The main procedures include exposure to virtual reality (passive calming scenery or interactive puzzle game) via Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures, participant self-report surveys (GAD-7, PHQ-9, PEG, VAS, SUDS, Likert, experience questions), and physician post-procedure survey. The study will enroll individuals 18 years or older who are scheduled to undergo common office-based ENT procedures (turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation, nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection) at Cedars Sinai.

Conditions

Pain; Anxiety; Chronic Rhinosinusitis (CRS); Nasal Obstruction; Nasal Polyp; Eustachian Tube Dysfunction; Dysphonia; Subglottic Stenosis (SGS)

Outcome Measures

Primary Outcomes (2)

• Pain assessed with visual analog scale

  Pain assessed on VAS (visual analog scale of 0-100 mm)

  Immediately before and immediately after the office-based ENT procedure during a single study visit

• Anxiety assessed with subjective units of distress scale

  Anxiety assessed using Subjective Units of Distress scale (0-100)

  Immediately before and immediately after the office-based ENT procedure during a single study visit

Secondary Outcomes (1)

• Clinician experience with VR use

  Immediately after the office-based ENT procedure during a single study visit

Other Outcomes (1)

• Patient satisfaction with VR use

  Immediately after the office-based ENT procedure during a single study visit

Study Arms (2)

Passive virtual reality

EXPERIMENTAL

passively watching calming scenery

Device: Virtual reality headset or goggles

Active virtual reality

EXPERIMENTAL

interactive game

Device: Virtual reality headset or goggles

Interventions

Virtual reality headset or goggles DEVICE

Exposure to virtual reality via Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures

Active virtual reality; Passive virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals 18 years old and older are included
• Individuals undergoing the following common office-based ENT procedures: turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation (Rhineaer/Vivaer), nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection
• Able to consent
• English speaking

You may not qualify if:

• History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, vertigo, or inability to use a handheld controller
• Any records flagged "break the glass" or "research opt out."
• History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, or vertigo
• Any records flagged "break the glass" or "research opt out."

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Offices East Tower

Los Angeles, California, 90048, United States

Location

Related Publications (10)

• Tyler MA, Lam K, Ashoori F, Cai C, Kain JJ, Fakhri S, Citardi MJ, Cattano D, Luong A. Analgesic Effects of Intravenous Acetaminophen vs Placebo for Endoscopic Sinus Surgery and Postoperative Pain: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Aug 1;143(8):788-794. doi: 10.1001/jamaoto.2017.0238.

  PMID: 28542675 BACKGROUND

• Chang J, Ninan S, Liu K, Iloreta AM, Kirke D, Courey M. Enhancing Patient Experience in Office-Based Laryngology Procedures With Passive Virtual Reality. OTO Open. 2021 Jan 8;5(1):2473974X20975020. doi: 10.1177/2473974X20975020. eCollection 2021 Jan-Mar.

  PMID: 33474521 BACKGROUND

• Gray ML, Goldrich DY, McKee S, Schaberg M, Del Signore A, Govindaraj S, Iloreta AM. Virtual Reality as Distraction Analgesia for Office-Based Procedures: A Randomized Crossover-Controlled Trial. Otolaryngol Head Neck Surg. 2021 Mar;164(3):580-588. doi: 10.1177/0194599820942215. Epub 2020 Aug 4.

  PMID: 32746734 BACKGROUND

• Pandrangi VC, Shah SN, Bruening JD, Wax MK, Clayburgh D, Andersen PE, Li RJ. Effect of Virtual Reality on Pain Management and Opioid Use Among Hospitalized Patients After Head and Neck Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Aug 1;148(8):724-730. doi: 10.1001/jamaoto.2022.1121.

  PMID: 35679057 BACKGROUND

• Moreau S, Therond A, Cerda IH, Studer K, Pan A, Tharpe J, Crowther JE, Abd-Elsayed A, Gilligan C, Tolba R, Ashina S, Schatman ME, Kaye AD, Yong RJ, Robinson CL. Virtual Reality in Acute and Chronic Pain Medicine: An Updated Review. Curr Pain Headache Rep. 2024 Sep;28(9):893-928. doi: 10.1007/s11916-024-01246-2. Epub 2024 Apr 8.

  PMID: 38587725 BACKGROUND

• Liu KY, Ninan SJ, Laitman BM, Goldrich DY, Iloreta AM, Londino AV 3rd. Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures. Laryngoscope. 2021 May;131(5):E1714-E1721. doi: 10.1002/lary.29148. Epub 2020 Oct 5.

  PMID: 33017065 BACKGROUND

• Gerceker GO, Salmal N, Bektas I. The effect of active and passive virtual reality distractions on phlebotomy-related emotional behavior, pain, anxiety, and fear in children: A randomized controlled trial. J Pediatr Nurs. 2025 Jul-Aug;83:190-198. doi: 10.1016/j.pedn.2025.05.005. Epub 2025 May 12.

  PMID: 40359712 BACKGROUND

• Xiang H, Shen J, Wheeler KK, Patterson J, Lever K, Armstrong M, Shi J, Thakkar RK, Groner JI, Noffsinger D, Giles SA, Fabia RB. Efficacy of Smartphone Active and Passive Virtual Reality Distraction vs Standard Care on Burn Pain Among Pediatric Patients: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2112082. doi: 10.1001/jamanetworkopen.2021.12082.

  PMID: 34152420 BACKGROUND

• Bani Mohammad E, Ahmad M. Virtual reality as a distraction technique for pain and anxiety among patients with breast cancer: A randomized control trial. Palliat Support Care. 2019 Feb;17(1):29-34. doi: 10.1017/S1478951518000639. Epub 2018 Sep 10.

  PMID: 30198451 BACKGROUND

• Shetty V, Suresh LR, Hegde AM. Effect of Virtual Reality Distraction on Pain and Anxiety During Dental Treatment in 5 to 8 Year Old Children. J Clin Pediatr Dent. 2019;43(2):97-102. doi: 10.17796/1053-4625-43.2.5. Epub 2019 Feb 7.

  PMID: 30730798 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders; Nasal Obstruction; Nasal Polyps; Dysphonia

Interventions

Eye Protective Devices

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Voice Disorders; Laryngeal Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Dennis M Tang, MD

CONTACT

310-423-1220; Dennis.Tang2@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician ENT

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)